UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
__________________
FORM
8-K
__________________
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event
reported): February
23, 2010
Lexicon
Pharmaceuticals, Inc.
(Exact
name of registrant as specified in its charter)
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Delaware
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000-30111
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76-0474169
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(State
or other jurisdiction of
incorporation
or organization)
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(Commission
File Number)
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(I.R.S.
Employer
Identification
Number)
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8800
Technology Forest Place
The
Woodlands, Texas 77381
(Address
of principal executive
offices
and Zip Code)
(281)
863-3000
(Registrant’s
telephone number,
including
area code)
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligations of the registrant under any of the following
provisions:
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□
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Written
communications pursuant to Rule 425 under the Securities Act
(17 CFR 230.425)
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□
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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□
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act
(17 CFR 240.14d-2(b))
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□
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act
(17 CFR 240.13e-4(c))
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Item
2.02
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Results
of Operations and Financial
Condition
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On
February 23, 2010, we issued a press release to report our financial results for
the quarter and year ended December 31, 2009. A copy of the press
release is attached to this current report on Form 8-K as
Exhibit 99.1.
The
information in this Form 8-K and the Exhibit attached to this Form 8-K shall not
be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of
1934 (the “Exchange Act”) or otherwise subject to the liabilities of that
section, nor shall it be deemed incorporated by reference in any filing under
the Securities Act of 1933 or the Exchange Act, except as expressly set forth by
specific reference in such a filing.
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Item
9.01
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Financial Statements and
Exhibits
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(d) Exhibits
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Exhibit No.
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Description
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99.1
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—
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Press
Release of Lexicon Pharmaceuticals, Inc. dated February 23,
2010
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2
Signatures
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
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Lexicon
Pharmaceuticals, Inc.
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Date: February
23, 2010
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By:
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/s/
Jeffrey L.
Wade
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Jeffrey
L. Wade
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Executive Vice President
and
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General
Counsel
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3
Index
to Exhibits
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Exhibit No.
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Description
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99.1
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—
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Press
Release of Lexicon Pharmaceuticals, Inc. dated February 23,
2010
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Exhibit
99.1
LEXICON
PHARMACEUTICALS PROVIDES CLINICAL PIPELINE UPDATE AND REPORTS 2009 FOURTH
QUARTER AND FULL YEAR FINANCIAL RESULTS
Conference
Call and Webcast at 11:00 a.m. Eastern Time
The Woodlands, Texas, February 23,
2010 – Lexicon
Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused
on discovering and developing breakthrough treatments for human disease, today
updated its drug development progress and reported financial results for the
three months and year ended December 31, 2009.
“We have
now established proof-of-concept for two of our four clinical programs, with
positive results in Phase 2 clinical trials for both LX1031 in IBS and LX4211 in
type 2 diabetes,” said Dr. Arthur T. Sands,
president and chief executive officer of Lexicon. “We look forward to
reporting Phase 2 clinical results from our next two programs, LX2931 for
rheumatoid arthritis and LX1032 for carcinoid syndrome.”
Key
Developments of 2009
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§
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Lexicon
reported positive results from the Phase 2a clinical trial of its drug
candidate for non-constipating irritable bowel
syndrome (IBS), LX1031, an
inhibitor of tryptophan hydroxylase that acts locally to reduce serotonin
synthesis in the gastrointestinal tract. Top-line data
demonstrated that the high dose of LX1031 produced
statistically-significant improvements in a global assessment of relief of
IBS pain and discomfort and in stool consistency as compared to placebo —
clinical benefits that correspond with a reduction in serotonin
synthesis.
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§
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Lexicon
completed Phase 2a studies of its drug candidate for type 2
diabetes, LX4211, an
inhibitor of sodium-glucose cotransporter 2 (SGLT2). Top-line
data from the Phase 2a trial, reported in January 2010, showed
statistically-significant and rapid improvements in multiple parameters in
patients with type 2 diabetes, including improved glycemic control and
reduced HbA1c within four weeks. In addition, reductions in weight, blood
pressure, and triglyceride levels were observed for both treatment arms
relative to placebo.
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§
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Lexicon
advanced LX2931, an
inhibitor of sphingosine-1-phosphate (S1P) lyase, into a Phase 2a study in
patients with rheumatoid
arthritis. The Phase 2 clinical trial is designed as a
12-week, randomized, double-blind, placebo-controlled study to evaluate
the safety and tolerability of LX2931 and its effects on symptoms
associated with rheumatoid arthritis. With enrollment in the study
proceeding ahead of schedule, the Company has filed for regulatory
authorization to permit enrollment of up to 200 patients, an increase from
the originally-planned enrollment of up to 120 patients, which will
increase the likelihood of observing a positive statistical trend. The
study is being conducted at multiple centers in the United States and
Eastern Europe. Top-line data from the expanded trial are
expected to be available around the end of the
year.
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§
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Lexicon
continues to enroll patients in a Phase 2a study of its drug candidate for
carcinoid
syndrome, LX1032, an
inhibitor of tryptophan hydroxylase that reduces peripheral serotonin
production without affecting brain serotonin levels. The Phase
2 clinical trial is designed as a randomized, double-blind,
placebo-controlled study to evaluate the safety and tolerability of LX1032
and its effects on symptoms associated with carcinoid
syndrome. The study is expected to include up to 28 patients
with carcinoid syndrome who are symptomatic despite treatment with
currently available therapy. Top-line data from the trial are
expected to be available in the second half of
2010.
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§
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In
October 2009, Lexicon completed the public offering and sale of 38.3
million shares of its common stock at $1.50 per share. The net
proceeds of the offering were $55.2 million, after deducting underwriting
discounts and offering expenses.
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LX1031
and LX1032 are being developed in a product development collaboration with
Symphony Capital Partners, L.P. and its co-investors.
Financial
Results
Revenues: Lexicon’s
revenues for the three months ended December 31, 2009 decreased 78 percent to
$1.4 million from $6.4 million for the corresponding period in
2008. The decrease was primarily attributable to reduced revenues
under Lexicon’s alliances with N.V. Organon, Bristol-Myers Squibb and Genentech,
Inc., partially offset by increases in revenue under the company’s collaboration
with Taconic Farms, Inc. For the year ended December 31, 2009,
revenues decreased 67 percent to $10.7 million from $32.3 million for the
corresponding period in 2008.
Research and Development
Expenses: Research and development expenses for the three
months ended December 31, 2009 decreased 16 percent to $18.8 million from $22.4
million for the corresponding period in 2008. The decrease was
primarily attributable to lower external preclinical research and development
expenses as well as lower salary and benefit costs, partially offset by higher
external clinical research and development expenses. For the year
ended December 31, 2009, research and development expenses decreased 24 percent
to $81.2 million from $107.2 million for the corresponding period in
2008.
General and Administrative
Expenses: General and administrative expenses for the three
months ended December 31, 2009 decreased nine percent to $4.4 million from $4.9
million for the corresponding period in 2008. The decrease was
primarily attributable to lower consulting and stock-based compensation
expenses. For the year ended December 31, 2009, general and
administrative expenses decreased 10 percent to $19.4 million from $21.6 million
for the corresponding period in 2008.
Net Loss Attributable to Lexicon
Pharmaceuticals, Inc.: Net loss for the three months ended
December 31, 2009 was $22.0 million, or $0.13 per share, compared to a net loss
of $15.4 million, or $0.11 per share, in the corresponding period in
2008. Net loss for the year ended December 31, 2009 was $82.8
million, or $0.57 per share, compared to a net loss of $76.9 million, or $0.56
per share, for the corresponding period in 2008. For the three months
and year ended December 31, 2009, net loss included non-cash, stock-based
compensation expense of $1.2 million and $5.3 million,
respectively. For the three months and year ended December 31, 2008,
net loss included non-cash, stock-based compensation expense of $1.7 million and
$6.5 million, respectively.
Cash and
Investments: As of December 31, 2009, Lexicon had $125.1
million in cash and investments net of its obligations under the credit line
secured by its auction rate securities, as compared to $87.3 million as of
September 30, 2009 and $158.8 million as of December 31, 2008.
Lexicon
Conference Call:
Lexicon
management will hold a conference call to discuss its clinical development
progress and financial results for 2009 and financial guidance for 2010 at 11:00
a.m. Eastern Time on February 23, 2010. The dial-in number for the
conference call is 888-220-1244 (within the US/Canada) or 706-679-5615
(international). The conference ID for all callers is
57354686. Investors can access a live webcast of the call at www.lexpharma.com. An
archived version of the webcast will be available on the website through March
2, 2010.
About
Lexicon
Lexicon
is a biopharmaceutical company focused on discovering and developing
breakthrough treatments for human disease. Lexicon currently has five
drug candidates in development for autoimmune disease, carcinoid syndrome,
diabetes, glaucoma and irritable bowel syndrome, all of which were discovered by
Lexicon’s research team. Lexicon has used its proprietary gene
knockout technology to identify more than 100 promising drug
targets. Lexicon has focused drug discovery efforts on these
biologically-validated targets to create its extensive pipeline of clinical and
preclinical programs. For additional information about Lexicon and
its programs, please visit www.lexpharma.com.
Safe
Harbor Statement
This
press release contains “forward-looking statements,” including statements
relating to Lexicon’s clinical development of LX1031, LX1032, LX2931, and LX4211
and the potential therapeutic and commercial potential of LX1031, LX1032,
LX2931, and LX4211. This press release also contains forward-looking
statements relating to Lexicon’s growth and future operating results, discovery
and development of products, strategic alliances and intellectual property, as
well as other matters that are not historical facts or
information. All forward-looking statements are based on management’s
current assumptions and expectations and involve risks, uncertainties and other
important factors, specifically including those relating to Lexicon’s ability to
successfully conduct clinical development of LX1031, LX1032, LX2931, and LX4211
and preclinical and clinical development of its other potential drug candidates,
advance additional candidates into preclinical and clinical development, obtain
necessary regulatory approvals, achieve its operational objectives, obtain
patent protection for its discoveries and establish strategic alliances, as well
as additional factors relating to manufacturing, intellectual property rights,
and the therapeutic or commercial value of its drug candidates, that may cause
Lexicon’s actual results to be materially different from any future results
expressed or implied by such forward-looking statements. Information
identifying such important factors is contained under “Factors Affecting
Forward-Looking Statements” and “Risk Factors” in Lexicon’s annual report on
Form 10-K for the year ended December 31, 2008, as filed with the Securities and
Exchange Commission. Lexicon undertakes no obligation to update or
revise any such forward-looking statements, whether as a result of new
information, future events or otherwise.
# # #
Contact for
Lexicon:
D. Wade
Walke
Director,
Corporate Communications
281/863-3046
wwalke@lexpharma.com
Lexicon
Pharmaceuticals, Inc.
Selected
Financial Data
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Consolidated
Statements of Operations Data
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Three
Months Ended
December
31,
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Year
Ended
December
31,
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||||||||||||||
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(In
thousands, except per share data)
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2009
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2008
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2009
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2008
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(unaudited)
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(unaudited)
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Revenues:
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Collaborative research
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$ | 1,292 | $ | 4,388 | $ | 9,334 | $ | 27,177 | ||||||||
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Subscription and license fees
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120 | 1,962 | 1,366 | 5,144 | ||||||||||||
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Total revenues
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1,412 | 6,350 | 10,700 | 32,321 | ||||||||||||
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Operating
expenses:
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||||||||||||||||
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Research
and development, including stock-based compensation
of
$694, $1,028, $3,022 and $3,941, respectively
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18,834 | 22,364 | 81,238 | 107,232 | ||||||||||||
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General
and administrative, including stock-based compensation
of
$502, $691, $2,252 and $2,559, respectively
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4,425 | 4,875 | 19,418 | 21,624 | ||||||||||||
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Total operating expenses
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23,259 | 27,239 | 100,656 | 128,856 | ||||||||||||
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Loss
from operations
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(21,847 | ) | (20,889 | ) | (89,956 | ) | (96,535 | ) | ||||||||
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Gain
(loss) on investments, net
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165 | 2,008 | 1,173 | (1,314 | ) | |||||||||||
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Interest
income
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211 | 607 | 880 | 5,762 | ||||||||||||
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Interest
expense
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(786 | ) | (671 | ) | (2,966 | ) | (2,691 | ) | ||||||||
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Other
expense, net
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(513 | ) | (485 | ) | (2,550 | ) | (2,106 | ) | ||||||||
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Consolidated
loss before income taxes
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(22,770 | ) | (19,430 | ) | (93,419 | ) | (96,884 | ) | ||||||||
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Income
tax benefit
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— | — | 102 | — | ||||||||||||
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Consolidated
net loss
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(22,770 | ) | (19,430 | ) | (93,317 | ) | (96,884 | ) | ||||||||
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Loss
attributable to noncontrolling interest in Symphony Icon, Inc.
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765 | 4,013 | 10,537 | 20,024 | ||||||||||||
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Net
loss attributable to Lexicon Pharmaceuticals, Inc.
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$ | (22,005 | ) | $ | (15,417 | ) | $ | (82,780 | ) | $ | (76,860 | ) | ||||
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Net
loss attributable to Lexicon Pharmaceuticals, Inc. per common share, basic
and diluted
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$ | (0.13 | ) | $ | (0.11 | ) | $ | (0.57 | ) | $ | (0.56 | ) | ||||
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Shares
used in computing net loss attributable to Lexicon Pharmaceuticals, Inc.
per common share, basic and diluted
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169,872 | 136,797 | 145,465 | 136,797 | ||||||||||||
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Consolidated
Balance Sheet Data
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As
of December 31,
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As
of December 31,
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||||||
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(In
thousands)
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2009
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2008
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||||||
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(unaudited)
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||||||||
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Cash
and investments, including cash and investments held by Symphony Icon,
Inc.
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$ | 162,513 | $ | 158,798 | ||||
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Obligations
under line of credit
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(37,435 | ) | — | |||||
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Cash
and investments, net of obligations under line of credit
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125,078 | 158,798 | ||||||
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Property
and equipment, net
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58,754 | 65,087 | ||||||
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Goodwill
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25,798 | 25,798 | ||||||
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Total
assets
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257,761 | 261,508 | ||||||
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Deferred
revenue
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15,154 | 19,884 | ||||||
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Current
and long-term debt, including line of credit
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66,964 | 30,492 | ||||||
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Noncontrolling
interest in Symphony Icon, Inc.
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(290 | ) | 10,247 | |||||
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Accumulated
deficit
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(570,175 | ) | (487,395 | ) | ||||
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Total
Lexicon Pharmaceuticals, Inc. stockholders’ equity
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163,787 | 185,580 | ||||||